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BIG PHARMACEUTICALS, INC.

Protocol No.: SAMPLE


Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

CONTROLLER QUALIFICATION PROTOCOL FOR


CIP / SIP CONTROL SYSTEM
The attached protocol has been approved for
format/content and is acceptable for execution.

Prepared By:

The attached protocol has been completed, the


results reviewed and found to be acceptable.

Date:
I.Q. Corporation

Format Approval

Content Approval

ENGINEERING:

ENGINEERING:

SIGNATURE

SIGNATURE

P. PIPER

Date:

P. PIPER

PRINT

PRINT

QUALITY ASSURANCE:

QUALITY ASSURANCE:

SIGNATURE

SIGNATURE

D. NAMED

Date:

D. NAMED

PRINT

PRINT

PRODUCTION:

PRODUCTION:

SIGNATURE

SIGNATURE

D. NAMED

Date:

D. NAMED

PRINT

PRINT

REGULATORY:

REGULATORY:

SIGNATURE

SIGNATURE

S. NAMED
PRINT

SAMPLE

Date:

S. NAMED

Date:

Date:

Date:

Date:

PRINT

Page 1 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

TABLE OF CONTENTS

1.0

Purpose

2.0

Scope

3.0

Responsibilities

4.0

References

5.0

System/Equipment Description

6.0

Rationale

7.0

Procedure

8.0

7.1

Controller Qualification

7.2

Acceptance Criteria

Abbreviations

SAMPLE

Page 2 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
1.0

PURPOSE
The purpose of this Controller Qualification (CQ) Protocol is to verify that the CIP/SIP
Control System is installed in accordance with design specifications, manufacturer's
recommendations, and applicable vendor/engineering drawings.

2.0

SCOPE
This Controller Qualification Protocol will be performed on the CIP/SIP Control
System, located in Building 88.

3.0

4.0

RESPONSIBILITIES
3.1

The Validation Department has overall responsibility for the execution


of the Validation Program and scheduling of the validation activities.

3.2

The Maintenance/Engineering Manufacturing and QA Validation


Departments are responsible for provisions of all applicable standard
operating procedures (SOPs).

3.3

The Manufacturing/Maintenance Department has responsibility for


providing the required operators, materials and test equipment for the
operation and validation of the system.

3.4

The Validation Committee is responsible for the review of the


Qualification Protocol for format, content and acceptability approval for
execution.

REFERENCES
4.1

SAMPLE

Engineering, validation and manufacturer's documents and drawings used to


develop and execute the Controller Qualification Protocol are listed on the
following forms:
4.1.1

Drawings

4.1.2

Manuals

4.1.3

Specifications

4.1.4

Procedures

Page 3 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

5.0

SYSTEM/EQUIPMENT DESCRIPTION
This protocol addresses the Big Pharma CIP/SIP Control System for Building 88. The
primary function of the CIP/SIP Control System is to perform the sequencing required
to clean the different process piping and equipment in the Big Pharma 88 building.
The correct sequencing is verified through the use of feedback limit switches on each
value and device. CIP/SIP process data is printed on Kaye Digistrip recorders located
in each process area. The process data is directly transmitted, as an analog signal,
from each instrument to each kaye channel.
5.1

The control system contains three primary hardware subsystems:


A.

PLC Subsystem

B.

Main Operator Control Station

C.

Remote Operator Control Station

5.1.1

SAMPLE

The PLC Subsystem contains the primary processing power for the
entire system. The other subsystems communicate directly to the PLC
Subsystem but cannot operate without it. The PLC Subsystem is
directly responsible for the execution of all CIP/SIP logic The
components of the PLC Subsystems are as follows:
A.

PLC 5/40 Programmable logic controller located in panel CP-01


on the Powerhouse.

B.

Action Instruments control coprocessor. This industrial 386 PC


handles communication with the Nematron Remote Operator
Control Stations and the Thornton Instrument Network. It is
located in panel CP-01 on the Powerhouse.

C.

Instrumentation:
The majority of the input sensors are
Thornton instruments.
They measure flow, conductivity,
temperature and levels. The Thornton 770 PCs are devices
which can process four different measurements simultaneously.
Each of the 770 PCs transmitters is connected to a two wire
local area network (LAN) called T-NET.
There are two
separate T-NETS within the plant. The instrument readings are
digitized and transmitted over these T-NETs to the control
coprocessor. The data is then written to the PLC as scaled,
floating point values. The few inputs that are not from the
Thornton network are wired directly to the PLCs analog input
modules.
These instrumentation devices are located
throughout the plant.

Page 4 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
D.

An I/O Subsystem including:


1.

Allen Bradley Digital Input/Output Modules

2.

Allen Bradley Analog Input/Output Modules

3.

SMC Solenoid Valve Banks: These are outputs on the


Allen Bradley remote I/O network.

These devices are located throughout the plant.


E.

CIP Batch Printer:


A single, serial, dot matrix, printer is
connected to both the Main Operator Control Station and the
Control Coprocessor. It records CIP events as they occur. It is
located in panel CP-22 on the Powerhouse.

5.1.2

The Main Operator Control Station Subsystem is located in CP-01 on


the Powerhouse. It consists of an Allen Bradley Panelview, model
2711-KCI. This station is primarily for giving the operator an overall
look at the system status. Graphic displays provide information on the
status of devices being used by the system. No CIP devices can be
controlled from this station. It is for monitoring only.

5.1.3

The Remote Operator Control Station Subsystem consists of four


Nematron 120 industrial terminals. There is one located in:
A.

Suite 100

B.

Suite 200

C.

Suite 300

D.

Suite 400

The Remote Operator Control Stations are the primary interface


between the operator and the central system. It is from these
consoles that automated cleaning sequences are selected and started.
The Remote Operator Control Stations also provide information about
the progress of a cleaning sequence.

SAMPLE

Page 5 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

6.0

RATIONALE
Where appropriate, testing will be conducted at the field devices and at the PLC to
insure proper system functioning. Testing should not be conducted at field devices
when equipment or personnel safety could be compromised.

7.0

PROCEDURE
7.1

SAMPLE

CONTROLLER QUALIFICATION
7.1.1

The specific requirements for the Controller Qualification are provided


on the following forms entitled Controller Qualification. These data
forms have been developed to provide completeness, consistency and
accuracy of data collection and inspection required.

7.1.2

The primary purpose of the Controller Qualification is to run the process


equipment and control systems through its paces and carefully test and
document related activities. Document operational inspections and test
results with black, indelible ink, ball-point pen on the forms incorporated
or attached to this protocol. Unless instructed by the protocol, test and
operational steps may be performed out of sequence.

7.1.3

Testing performed by a third party approved by Big Pharma is


acceptable. The results shall be affixed to the appropriate attachment
as directed by the protocol.

7.1.4

Proper completion and review of the Controller Qualification forms by a


second, independent validation person will constitute completion of the
Controller Qualification activity.

7.1.5

CONTROLLER QUALIFICATION TEST METHODOLOGY: The installation


data sheets will contain but not be limited to the following document forms:
A.

Controller Qualification Prerequisites

B.

Purchase Order Inspection

C.

Programmable Logic Controller Verification

D.

Ancillary System Specification Verification

E.

Hardware Configuration Verification -Jumpers

F.

Input/Output List and Points Verification

G.

Major Hardware Component Verification

Page 6 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

SAMPLE

H.

Utilities - Electrical

I.

Supply Voltage and Circuit Protection Verification

J.

Software Component Verification

K.

Software Application Code Verification

L.

Security Code Test

M.

Functional Test Verification

N.

Alarm Verification

O.

Power Failure Test

P.

Environmental Operating Parameters Verification

Q.

Test Equipment

R.

Drawings

S.

Spare Parts List

T.

Manuals

U.

Standard Operating Procedures

V.

Amendment(s) and Deviation(s)

W.

Summary and Conclusions

Page 7 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

7.2

ACCEPTANCE CRITERIA
The Acceptance Criteria are the specific set of standards or design
specifications that each piece of equipment or system must meet in order to
demonstrate a high level of confidence that the system/equipment is capable of
consistently operating within established limits or tolerances.
Acceptance Criteria for Controller Qualification (CQ) may include, but is not
limited to, the follow ing requirements:
Instrumentation:

Verification that the controllers and components are appropriately identified


and installed according to manufacturers specifications.
Verification that all configurable switches and jumpers are documented for
baseline information.
Verification that wiring of the control system hardware components to the
field devices have been properly identified and functional per specified
drawings.
Verification that the input and outputs modules are properly installed per
specified drawings.
Verification that the ancillary control system(s) and association components
have been properly installed and identified per specified drawings.

Utilities:

Verification that the supplied utilities meet the vendors specified


requirements.
Verification that the individual system components are supplied with utilities
that meet the vendors specified requirements.
Verification that the circuit protection devices are installed and identified per
specified drawings.

Security:

Verification that the program security functions as specified by the vendor.

Softw are:

SAMPLE

Verification that the application software is the specified revision and that
any subsequent changes made are supported by Change Control SOP 214.

Page 8 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

Verification that the application code currently operating in the controller is


in a controlled and secured file location in both hard copy and computer disk
form.

Verification that the application code is properly annotated and all input and
output software variables have a unique point descriptor assigned to the
point.

Draw ings and Manuals:

Verification that current drawings and applicable manuals, such as vendor


installation, operation and maintenance manuals, are properly documented
and are accessible to the appropriate personnel.

Functional:

Verification that the control system operates as designed and in accordance


with the application software and applicable manufacturers specifications.

Alarm and Interlocks:

Verification that all field device alarms and interlocks are properly identified,
function as specified, and where applicable the appropriate response is
observed.

Pow er Failure:

Verification that the CPU and operator interface modules do not experience
a failure due to the removal of power.

Verification that during the Power Failure test, all devices default to a failsafe mode.

Verification that when power is restored, the CPU restarts the program
safely, or returns to an initial condition from which the operator can restart
the operation, and the operator interface panel recovers from the power
failure and is fully functional.

Environment:

SAMPLE

Verification that the environmental conditions for the control system


components are documented and that the temperature and relative humidity
are within the manufacturer's specification.

Page 9 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
8.0

ABBREVIATIONS

A
AC
A/C
amp
atm

Ampere
Air conditioning
Alternating Current
Ampere, also A
Atmosphere

mg
mHz
MHz
mm
mmHg

BTU
C
cfm

British Thermal Units


Degree Celsius
Cubic feet per minute

kVA

cGMP

NIST

cfu

Current Good Manufacturing


Practices
Colony forming unit

CQ
DPU

Controller Qualification
Distributed process units

OD
ohm/

e.g.,
F
ft./min.

For example; such as


Degree Fahrenheit
Feet per minute

OK
OQ
P&ID

GMP
gph
gpm
HEPA

Good Manufacturing Practices


Gallons per hour
Gallons per minute
High efficiency particulate air

PH
psf
psi
psig

hp
hr.
Hz

Horsepower
Hour
Hertz

RH
rpm
RTD

i.e.,
in

That is
Inch

s
SOP

IQ

Installation Qualification

k
kg
kV
kW
kWh
l

Kilo
Kilogram
Kilovolt
Kilowatt
Kilowatt-hour
Liter

sq. ft. or
SF
SS

g
V
W
w.c.

lb
m
mb
mfg.

Pound (avoirdupois)
Meter or milli
Millibar
Manufacturing

WIF
WFI
W.G.
w.g.

SAMPLE

NBS

N.V.

Milligram
Millihertz
Megahertz
Millimeter
Conventional millimeter of
mercury
Kilovolt ampere
National Bureau of
Standards
National Institute of
Standards & Technology
Not Visible - requires
disassembly
Outside diameter
The SI unit of electrical
resistance
Okay
Operational Qualification
Piping and Instrumentation
Diagram
Phase (3 PH)
Pounds per square foot
Pounds per square inch
Pounds per square inch,
gauge
Relative humidity
Revolutions per minute
Resistance temperature
detection
Second
Standard Operating
Procedures
Square feet or foot
Stainless steel
Micro
Microgram
Volt (240 V)
Watt
Water closet (Arch.) Or
water column (Mech.)
Weld Inspection Form
Water for Injection
Wire gage
Water gauge

Page 10 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
CONTROLLER QUALIFICATION PREREQUISITES
Before execution of Controller Qualification (CQ) Activities, the following prerequisites must be
addressed and found acceptable and approved by Big Pharma.

Prerequisites

Verified By / Date

System has been transferred from construction and startup is completed.


Construction Punch List and/or deviations documents
have been checked and approved by Big Pharma for
continuation in system completion.
Software specifications relative to the Controller System
of the machine are available.
Instrument Index has been reviewed and updated to
reflect current purchased/existing instruments
Current revisions to reference documents and/or drawing
have been verified.
Reference documents and/or drawings are available, or
assignment to procure them has been documented on
System Punch List.
Prerequisites are completed and reviewed prior to
execution of Controller Qualification.

______________________________________The Protocol Executor


SIGNATURE/DATE

______________________________________Big Pharma
SIGNATURE/DATE

SAMPLE

Page 11 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PURCHASE ORDER INSPECTION
Verify that the specified component is supplied and installed in accordance with specifications and
options indicated by their respective purchase orders. If a purchase order is not available, refer to
applicable drawings such as engineering drawings.
Equipment Name:
Manufacturer:
Equipment ID No.:
Model No.:
Serial No.:

Verified By:

Location:
Purchase Order:
Equipment Status (CIRCLE ONE):

Verified By:
New

Transferred/Used

Location of Purchase Order:


Equipment Supplied and
Installed per Purchase Order:

(Yes / No):

COMMENTS:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 12 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Manufacturer

Allen-Bradley

Model No.

PLC 5/40

Serial No.

Not Specified

Location

CP-01

NEMA Rating

Not Specified

UL Rated (Yes / No)

Yes (UL listed CSA Approved)

Number of Inputs Connected

459 used out of 504 available

Number of Outputs Connected

91 used out of 124 available

Processor Unit, Slot 0 / Cat. No.

1785-L40B 1

Rack 0, Group 0

Spare slot

Rack 0, Group 1

Spare slot

Rack 0, Group 2

Spare slot

Rack 0, Group 3

Spare slot

Rack 0, Group 4

Spare slot

Rack 0, Group 5

Spare slot

Reference Documents Name and No.:

IQC Dwg ESO493-05.B07


Sheet 3 of 23
Enhanced Ethernet PLC5
Programmable controllers users
manual (AB #1785-6.5-12)

COMMENTS:
1

Contains the capacity for 48K of programming instructions.

CP-01 is on Powerhouse.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 13 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Rack 0, Group 6

Spare slot

Rack 0, Group 7

Spare slot

Rack 1, Group 0

Spare slot

Rack 1, Group 1

Spare slot

Rack 1, Group 2

Spare slot

Rack 1, Group 3

Spare slot

Rack 1, Group 4: Analog Output Module

4 Analog Output Module


Model 1771-OFE2
4 Analog Output Module
Model 1771-OFE2
4 Analog Output Module
Model 1771-OFE2
8 Analog Input Module
Model 1771-IFE
IQC Dwg No. ES0493-05.B7
Sheet 3 of 23
1771-IFE Analog Input Users
Manual (AB #1771-6.5.90)
1771-OFE Analog Output Users
Manual (AB #1771-6.5.30)

Rack 1, Group 5: Analog Output Module


Rack 1, Group 6: Analog Output Module
Rack 1, Group 7: Analog Input Module
Reference Documents Name and No.:

COMMENTS:
1

These modules are located in CP-01 on Powerhouse.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 14 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Rack 2, Group 0: 16 Digital Input Module

1771-IBD

Rack 2, Group 1: 16 Digital Input Module

1771-IBD

Rack 2, Group 2: 16 Digital Input Module

1771-IBD

Rack 2, Group 3: 16 Digital Input Module

1771-IBD

Rack 2, Group 4: 16 Digital Input Module

1771-IBD

Rack 2, Group 5: 16 Digital Input Module

1771-IBD

Rack 2, Group 6

Spare slot

Rack 2, Group 7

Spare slot

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.B08


Sheet 4 of 23
1771-IBD 10-30VDC Input
Module Installation Book
(AB #1771-2.75)
1771-OBD 10-30VDC Output
Module Installation Book
(AB #1771-2.76)

COMMENTS:
1

These modules are located in CP-01 on Powerhouse.

This chassis also contains a remote I/O adapter, model 1771-ASB, in the leftmost slot.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 15 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Rack 3, Group 0: 16 Digital Output Module

1771-OBD

Rack 3, Group 1: 16 Digital Output Module

1771-OBD

Rack 3, Group 2

Spare slot

Rack 3, Group 3

Spare slot

Rack 3, Group 4

Spare slot

Rack 3, Group 5

Spare slot

Rack 3, Group 6

Spare slot

Rack 3, Group 7

Spare slot

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.B08


Sheet 4 of 23
1771-OBD 10-30VDC Input
Module Installation Book
(AB #1771-2.76)
1771-ASB Users Manual
(AB #1771-2.48)

COMMENTS:
1

These modules are located in CP-01 Powerhouse.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 16 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Rack 4, Group 0: 16 Digital Input Module

1771-IBD

Rack 4, Group 1: 16 Digital Input Module

1771-IBD

Rack 4, Group 2: 16 Digital Input Module

1771-IBD

Rack 4, Group 3: 16 Digital Input Module

1771-IBD

Rack 4, Group 4: 16 Digital Input Module

1771-IBD

Rack 4, Group 5: 16 Digital Input Module

1771-IBD

Rack 4, Group 6: 16 Digital Input Module

1771-IBD

Rack 4, Group 7: 16 Digital Input Module

1771-IBD

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.C37


Sheet 3 of 44
1771-IBD 10-30VDC Input
Module Installation Book
(AB #1771-2.75)
1771-OBD 10-30VDC Input
Module Installation Book
(AB #1771-2.76)
1771-ASB Users Manual
(AB #1771-2.48)

COMMENTS:
1

This chassis also contains remote I/O adapter module in the left most slot. Model #1771-ASB

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 17 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Rack 5, Group 0: 16 Digital Input Module

1771-IBD

Rack 5, Group 1: 16 Digital Input Module

1771-IBD

Rack 5, Group 2: 16 Digital Input Module

1771-IBD

Rack 5, Group 3: 16 Digital Input Module

1771-IBD

Rack 5, Group 4: 16 Digital Output Module

1771-OBD

Rack 5, Group 5: 16 Digital Output Module

1771-OBD

Rack 5, Group 6

Spare slot

Rack 5, Group 7: 8 Analog Input Module

1771-IFE

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.C37


Sheet 3 of 44
1771-IBD 10-30VDC Input
Module Installation Book
(AB #1771-2.75)
1771-OBD 10-30VDC Input
Module Installation Book
(AB #1771-2.76)
1771-IFE Analog Input Users
Manual (AB #1771-6.5.90)

COMMENTS:
1

These modules are located in Panel CP-01A,

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 18 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Rack 6, Group 0: 16 Digital Input Module

1771-IBD

Rack 6, Group 1: 16 Digital Input Module

1771-IBD

Rack 6, Group 2: 16 Digital Input Module

1771-IBD

Rack 6, Group 3: 16 Digital Input Module

1771-IBD

Rack 6, Group 4: 16 Digital Input Module

1771-IBD

Rack 6, Group 5: 16 Digital Input Module

1771-IBD

Rack 6, Group 6: 16 Digital Input Module

1771-IBD

Rack 6, Group 7: 16 Digital Input Module

1771-IBD

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.C38


Sheet 4 of 44
1771-IBD 10-30VDC Input
Module Installation Book
(AB #1771-2.75)

COMMENTS:
1

These modules are located in Panel CP-01A, Mechanical Room

This chassis also contains a remote I/O adapter, model 1771-ASB, in the leftmost slot.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 19 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Rack 7, Group 0: 16 Digital Input Module

1771-IBD

Rack 7, Group 1: 16 Digital Output Module

1771-OBD

Rack 7, Group 2: 16 Digital Output Module

1771-OBD

Rack 7, Group 3

Spare Slot

Rack 7, Group 4

Spare Slot

Rack 7, Group 5

Spare Slot

Rack 7, Group 6

Spare Slot

Rack 7, Group 7: 8 Analog Input Module

1771-IFE

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.C38


Sheet 4 of 44
1771-IBD 10-30VDC Input
Module Installation Book
(AB #1771-2.75)
1771-OBD 10-30VDC Output
Module Installation Book
(AB #1771-2.76)
1771-IFE Analog Input Users
Manual (AB #1771-6.5.90)

Actual

COMMENTS:
1

These modules are located in Panel CP-01A, Mechanical Room

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 20 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Rack 10, Group 0: 16 Digital Input Module

1771-IBD

Rack 10, Group 1: 16 Digital Input Module

1771-IBD

Rack 10, Group 2: 16 Digital Output Module

1771-OBD

Rack 10, Group 3: 16 Digital Input Module

1771-IBD

Rack 10, Group 4

Spare Slot

Rack 10, Group 5

Spare Slot

Rack 10, Group 6

Spare Slot

Rack 10, Group 7

Spare Slot

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.C39


Sheet 5 of 44
1771-IBD 10-30VDC Input
Module Installation Book
(AB #1771-2.75)
1771-OBD 10-30VDC Output
Module Installation Book
(AB #1771-2.76)

Actual

COMMENTS:
1
2
3

These modules are located in Panel CP-01A, Mechanical Room


This chassis also contains a remote I/O adapter, model 1771-ASB, in the leftmost slot.
NOTE - Because Allen Bradley uses octal numbering, racks 8 and 9 do not exist.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 21 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
PROGRAMMABLE LOGIC CONTROLLER VERIFICATION (CONTD)
Controller Tag ID No.: PLC CIP
Controller Description: Allen Bradley PLC-5 Programmable Logic Controller
Verify the following information about the controller to ensure that it is installed in accordance with
design specification.

Installation Verification Items

Specified

Actual

Rack 11, Group 0

Spare Slot

Rack 11, Group 1

Spare Slot

Rack 11, Group 2

Spare Slot

Rack 11, Group 3

Spare Slot

Rack 11, Group 4

Spare Slot

Rack 11, Group 5

Spare Slot

Rack 11, Group 6

Spare Slot

Rack 11, Group 7

Spare Slot

Reference Documents Name and No.:

IQC Dwg No. ES0493-05.C39


Sheet 5 of 44

COMMENTS:
1

These modules are located in Panel CP-01A, Mechanical Room

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 22 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY CONTROL SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Designated

Actual

System Type:

Operator Terminal

Manufacturer:

Allen-Bradley

ID No.:

Main OCS

Model No.:

Panelview 1200, 2711-KC1

Serial No.:

IMOGN95SK

Location:

CP-01 Powerhouse

NEMA Rating:

NEMA type 4

UL Rated: (Yes / No)

Yes

Firmware Version:

5.0

Reference Documents:

See below

COMMENTS:
1

Planelview operator terminals users manual (AB#2711-812).

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 23 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Operator Terminal

Manufacturer:

Nematron

Controller Tag ID No.:

CP-02

Model No.:

IWS-120

Serial No.:

Not Specified

Location:

CP-02

NEMA Rating:

NEMA 4X

UL Rated: (Yes / No)

Yes

Firmware Version:

2.00

Unit Rev:

Reference Documents:

Nematron series 110/120


installation and terminal guide
Doc. IWS-232.

COMMENTS:
1

This unit is configured as an RS-232 industrial terminal.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 24 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Operator Terminal

Manufacturer:

Nematron

Controller Tag ID No.:

CP-03

Model No.:

IWS-120

Serial No.:

Not Specified

Location:

CP-03

NEMA Rating:

NEMA 4X

UL Rated: (Yes / No)

Yes

Firmware Version:

2.00

Unit Rev:

Reference Documents:

Nematron series 110/120


installation and terminal guide
Doc. IWS-232.

COMMENTS:
1

This unit is configured as an RS-232 industrial terminal.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 25 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Operator Terminal

Manufacturer:

Nematron

Controller Tag ID No.:

CP-04

Model No.:

IWS-120

Serial No.:

Not Specified

Location:

CP-04 Suite 100

NEMA Rating:

NEMA 4X

UL Rated: (Yes / No)

Yes

Firmware Version:

2.00

Unit Rev:

Reference Documents:

Nematron series 110/120


installation and terminal guide
Doc. IWS-232.

COMMENTS:
1

This unit is configured as an RS-232 industrial terminal.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 26 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Operator Terminal

Manufacturer:

Nematron

Controller Tag ID No.:

CP-05

Model No.:

IWS-120

Serial No.:

Not Specified

Location:

CP-05 Suite 200

NEMA Rating:

NEMA 4X

UL Rated: (Yes / No)

Yes

Firmware Version:

2.00

Unit Rev:

Reference Documents:

Nematron series 110/120


installation and terminal guide
Doc. IWS-232.

COMMENTS:
1

This unit is configured as an RS-232 industrial terminal.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 27 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Operator Terminal

Manufacturer:

Nematron

Controller Tag ID No.:

CP-TT-07

Model No.:

IWS-120

Serial No.:

Not Specified

Location:

CP-TT-07 Suite 300

NEMA Rating:

NEMA 4X

UL Rated: (Yes / No)

Yes

Firmware Version:

2.00

Unit Rev:

Reference Documents:

Nematron series 110/120


installation and terminal guide
Doc. IWS-232.

COMMENTS:
1

This unit is configured as an RS-232 industrial terminal.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 28 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Operator Terminal

Manufacturer:

Nematron

Controller Tag ID No.:

CP-07

Model No.:

IWS-120

Serial No.:

Not Specified

Location:

CP-07 Suite 400

NEMA Rating:

NEMA 4X

UL Rated: (Yes / No)

Yes

Firmware Version:

2.00

Unit Rev:

Reference Documents:

Nematron series 110/120


installation and terminal guide
Doc. IWS-232.

COMMENTS:
1

This unit is configured as an RS-232 industrial terminal.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 29 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Industrial Computer

Manufacturer:

Action Instruments

Controller Tag ID No.:

Not Specified

Model No.:

CMPC-5BOXPC

Serial No.:

A316J

Location:

CP-01 Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Yes

Actual

COMMENTS:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 30 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Microprocessor Recorder

Manufacturer:

Kaye

Controller Tag ID No.:

CP-02

Model No.:

Digistrip 4S Plus

Serial No.:

Not Specified

Location:
NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Firmware Version

Not Specified

Reference Documents:

Kaye Digi 4S Plus users guide

COMMENTS:
1

This recorder is used to monitor both CIP/SIP parameters and process parameters.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 31 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Microprocessor Recorder

Manufacturer:

Kaye

Controller Tag ID No.:

CP-05

Model No.:

Digistrip 4S Plus

Serial No.:

Not Specified

Location:

Suite 200

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Firmware Version

Not Specified

Reference Documents:

Kaye Digi 4S Plus users guide

COMMENTS:
1

This recorder is used to monitor both CIP/SIP parameters and process parameters.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 32 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Microprocessor Recorder

Manufacturer:

Kaye

Controller Tag ID No.:


Model No.:

Digistrip 4S Plus

Serial No.:

Not Specified

Location:

Suite 300

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Firmware Version

Not Specified

Reference Documents:

Kaye Digi 4S Plus users guide

COMMENTS:
1

This recorder is used to monitor both CIP/SIP parameters and dispatch parameters.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 33 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Microprocessor Recorder

Manufacturer:

Kaye

Controller Tag ID No.:

CP-40

Model No.:

Digistrip 4S Plus

Serial No.:

Not Specified

Location:

Suite 400

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Firmware Version

Not Specified

Reference Documents:

Kaye Digi 4S Plus users guide

COMMENTS:
1

This recorder is used to monitor CIP/SIP and Lyo parameters.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 34 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Microprocessor Recorder

Manufacturer:

Kaye

Controller Tag ID No.:

CP-22

Model No.:

Digistrip 4S Plus

Serial No.:

Not Specified

Location:

Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Firmware Version

Not Specified

Reference Documents:

Kaye Digi 4S Plus users guide

COMMENTS:
1

This recorder is used to monitor only CIP/SIP parameters.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 35 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 10, Group 0

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-04

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:100/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 36 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 12, Group 0

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-08,

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:120/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 37 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 12, Group 2

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-08, Area

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:122/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 38 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents..

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 12, Group 4

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-09

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:124/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 39 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 12, Group 6

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-10, Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:126/0-15

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 40 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 14, Group 0

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:140/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 41 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 14, Group 2

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:142/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 42 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 14, Group 4

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-02

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:144/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 43 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 14, Group 6

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-02

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:146/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 44 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents..

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 15, Group 0

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-03

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:150/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 45 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 16, Group 0

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:160/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 46 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 16, Group 2

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:162/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 47 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 16, Group 4

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-06

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:164/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 48 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Solenoid Bank

Manufacturer:

SMC

Controller Tag ID No.:

Rack 16, Group 6

Model No.:

IN313-AB1

Serial No.:

Not Specified

Location:

CP-S-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

This device is connected to the CIP PLC 5/40 via a remote I/O link. The device is directly addressed as
0:166/0-15.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 49 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Instrument Network Transceiver

Manufacturer:

Thornton

Controller Tag ID No.:

Gateway 1, T-NET-2

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 Network Interface


Instruction Manual

COMMENTS:
1

Environmental operating specification: 32-122 F

Relative humidity specifications: 0-95% Non condensing

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

The Thornton instrument network address for this device is 2:128

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 50 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Temperature


Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-035/036

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any set-point
can be programmed to operate one of two output relays.
5

The Thornton instrument network address for this device is 2:56.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 51 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Temperature


Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-034/044

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any set-point
can be programmed to operate one of two output relays.
5

The Thornton instrument network address for this device is 2:55.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 52 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-038 / TT-040 / FT-039

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any set-point
can be programmed to operate one of two output relays. It has temperature compensation with automatic
reference to 25 C conductivity.
5

The Thornton instrument network address for this device is 2:51.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 53 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-041 / TT-043 / FT-042

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any set-point
can be programmed to operate one of two output relays. It has temperature compensation with automatic
reference to 25 C conductivity.
5

The Thornton instrument network address for this device is 2:52.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 54 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-048 / TT-047

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any set-point
can be programmed to operate one of two output relays. It has temperature compensation with automatic
reference to 25 C conductivity.
5

The Thornton instrument network address for this device is 2:53.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 55 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Temperature


Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-045/046

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-05

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 2:54.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 56 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Temperature


Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-625/626

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 2:11.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 57 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-623/624

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 2:12.

Verified By: ___________________________________________Date: ____________________


Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 58 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-683/695

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 2:13

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 59 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-699/700

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 2:14

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 60 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-111 / TT-105 / FT-106

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-08

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 2:81.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 61 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-531 / TT-532 / FT-530

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-08,

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 2:82.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 62 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-645/665

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-06

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 2:64.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 63 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-621 / TT-622

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-06

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 2:63.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 64 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-649 / TT-651 / FT-650

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-06

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 2:62.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 65 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-674 / TT-672 / FT-673

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-06

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 2:61.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 66 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents..

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-661/662

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-06

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 2:65.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 67 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Instrument Network Transceiver

Manufacturer:

Thornton

Controller Tag ID No.:

Gateway #2, T-NET-2

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-06

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 Network Interface


Instruction Manual

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

The Thornton instrument network address for this device is 2:129.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 68 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Instrument Network Transceiver

Manufacturer:

Thornton

Controller Tag ID No.:

Gateway #1, T-NET-1

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-02, Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 Network Interface Instruction


Manual

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

The Thornton instrument network address for this device is 1:128.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 69 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Temperature


Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-101

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-02, Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:23.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 70 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Temperature


/ Level Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-103 / LT-104

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-02, Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:21.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 71 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Temperature


/ Level Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-115 / LT-116

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-02, Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:22.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 72 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Conductivity


/ Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-123 / TT-125 / FT-124

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-03, Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 1:31.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 73 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller / Conductivity


/ Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-128 / TT-130 / FT-129

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-03, Powerhouse

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 1:32.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 74 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-144 / TT-145 / FT-133

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-04, Area 2

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 1:41.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 75 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-131 / TT-132

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-04, Area 2

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 1:42.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 76 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-219/220

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:74.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 77 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-212/233

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:73.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 78 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-205 / TT-207 / FT-206

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 1:72.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 79 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Conductivity / Flow Meter

Manufacturer:

Thornton

Controller Tag ID No.:

CIT-231 / TT-232 / FT-229

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays. It has temperature compensation with
automatic reference to 25 C conductivity.

The Thornton instrument network address for this device is 1:71.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 80 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-216

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:75.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 81 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-235

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:76.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 82 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Process Controller /
Temperature Meter

Manufacturer:

Thornton

Controller Tag ID No.:

TT-226

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 PC Process Controller


Instruction Manual PP.57-58

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

It has four individual software controlled set-points which can be set as a high or low limit. Any setpoint can be programmed to operate one of two output relays.

The Thornton instrument network address for this device is 1:77.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 83 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Instrument Network Transceiver

Manufacturer:

Thornton

Controller Tag ID No.:

Gateway #2, T-NET-1

Model No.:

770 PC

Serial No.:

Under front bezel

Location:

CP-TT-07

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

770 Network Interface


Instruction Manual

COMMENTS:
1

Environmental operating specification: 32-122 F.

Relative humidity specifications: 0-95% Non condensing.

This has an RS-232 Interface and a amp fuse circuit protection located on the back plane of the
printed circuit board.

The Thornton instrument network address for this device is 1:129.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 84 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Power Supply 24 VDC

Manufacturer:

Acopian

Controller Tag ID No.:

P1

Model No.:

A24H1200

Serial No.:

Not Specified

Location:

CP-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

Located in Panel CP-01 Powerhouse.

This device powers discrete I/O circuits and the SMC Solenoid bank valves.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 85 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Power Supply 30 VDC

Manufacturer:

Acopian

Controller Tag ID No.:

P2

Model No.:

A30MT210

Serial No.:

Not Specified

Location:

CP-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

Located in Panel CP-01 Powerhouse.

This device powers Analog I/O circuits.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 86 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Power Supply 24 VDC

Manufacturer:

Acopian

Controller Tag ID No.:

P3

Model No.:

A24MT210

Serial No.:

Not Specified

Location:

CP-01

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

Located in Panel CP-01 Powerhouse.

This device powers the SMC Solenoid bank electronics.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 87 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Power Supply

Manufacturer:

Allen Bradley

Controller Tag ID No.:

None

Model No.:

1771-P7

Serial No.:

Not Specified

Location:

CP-01, Chassis 1

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

Allen Bradley 1771-I/O Chassis Power supply product data


Pub. 1771-2.185

COMMENTS:
1

Located in Panel CP-01 Powerhouse.

This device supplies the 1st Chassis.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 88 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Power Supply

Manufacturer:

Allen Bradley

Controller Tag ID No.:

None

Model No.:

1771-P7

Serial No.:

Not Specified

Location:

CP-01, Chassis 2

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

Allen Bradley 1771-I/O Chassis Power supply product data


Pub. 1771-2.185

COMMENTS:
1

Located in Panel CP-01 Powerhouse.

This device supplies the 2nd Chassis.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 89 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Power Supply

Manufacturer:

Allen Bradley

Controller Tag ID No.:

None

Model No.:

1771-P7

Serial No.:

Not Specified

Location:

CP-01A, Chassis 3

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

Allen Bradley 1771-I/O Chassis Power supply product data


Pub. 1771-2.185

COMMENTS:
1

Located in Panel CP-01A .

This device supplies the 3rd Chassis.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 90 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Power Supply

Manufacturer:

Allen Bradley

Controller Tag ID No.:

None

Model No.:

1771-P7

Serial No.:

Not Specified

Location:

CP-01A, Chassis 4

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

Allen Bradley 1771-I/O Chassis Power supply product data


Pub. 1771-2.185

COMMENTS:
1

Located in Panel CP-01A .

This device supplies the 4th Chassis.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 91 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

Actual

System Type:

Power Supply

Manufacturer:

Allen Bradley

Controller Tag ID No.:

None

Model No.:

1771-P7

Serial No.:

Not Specified

Location:

CP-01A, Chassis 5

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Reference Documents:

Allen Bradley 1771-I/O Chassis Power supply product data


Pub. 1771-2.185

COMMENTS:
1

Located in Panel CP-01A .

This device supplies the 5th Chassis.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 92 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Power Supply 24 VDC

Manufacturer:

Acopian

Controller Tag ID No.:

P4

Model No.:

A24H1500

Serial No.:

Not Specified

Location:

CP-01A

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

Located in Panel CP-01A .

This device supplies the discrete I/O and the SMC Solenoid bank valves

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 93 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Power Supply 30 VDC

Manufacturer:

Acopian

Controller Tag ID No.:

P5

Model No.:

A30MT210

Serial No.:

Not Specified

Location:

CP-01A

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

Located in Panel CP-01A .

This device supplies the Analog I/O.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 94 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ANCILLARY SYSTEM SPECIFICATION VERIFICATION
Verify the controller contact ancillary system(s), and components, such as, controls, monitors,
processors, I/O modules, recorders, etc., are installed in accordance with applicable
documents.

Installation Verification Items

Specified

System Type:

Power Supply 24 VDC

Manufacturer:

Acopian

Controller Tag ID No.:

P6

Model No.:

A24MT210

Serial No.:

Not Specified

Location:

CP-01A

NEMA Rating:

Not Specified

UL Rated: (Yes / No)

Not Specified

Actual

Reference Documents:
COMMENTS:
1

Located in Panel CP-01A .

This device powers the SMC Solenoid bank electronics.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 95 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Controller Tag ID No.

Allen Bradley CPU Module PLC


5/40, 1785-L40BC
PLC CIP

Location

PLC chassis, left most slot, CP-01

Equipment Name

Jumper / Dip Switch


Configuration
SW1

Actual

See Below
Off
On

DH+ Address
SW2

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Off
On

Communication Mode
Comments:
Note: Processor is at DH+ address 24 and its communications mode should be set to RS-232.
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 96 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Actual

Controller Tag ID No.

Allen Bradley Analog Output


Module 1771-OFE
PLC CIP

Location

Rack 1, Group 4, CP-01

Equipment Name

Jumper / Dip Switch


Configuration

See Below
Last State Jumpers
1

Verify / Date

Comments:
Set for minimum output on rack fault.
Reference Documents:
Allen Bradley publication 1771-6.5.3.0

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 97 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Actual

Controller Tag ID No.

Allen Bradley Analog Output


Module 1771-OFE
PLC CIP

Location

Rack 1, Group 5, CP-01

Equipment Name

Jumper / Dip Switch


Configuration

See Below
Last State Jumpers
1

Verify / Date

Comments:
Set for minimum output on rack fault.
Reference Documents:
Allen Bradley publication 1771-6.5.3.0

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 98 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Actual

Controller Tag ID No.

Allen Bradley Analog Output


Module 1771-OFE
PLC CIP

Location

Rack 1, Group 6, CP-01

Equipment Name

Jumper / Dip Switch


Configuration

See Below
Last State Jumpers
1

Verify / Date

Comments:
Set for minimum output on rack fault.
Reference Documents:
Allen Bradley publication 1771-6.5.3.0

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 99 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Actual

Controller Tag ID No.

Allen Bradley Analog Input Module


1771-IFE
PLC CIP

Location

Rack 1, Group 7, CP-01

Equipment Name

Jumper / Dip Switch


Configuration
Last State Jumpers
Channel 1

Channel 2

See Below
Verify / Date

1
3

Last State Jumpers


Channel 5

29

31

11

Channel 6

13

Channel 3

27

15

Verify / Date

33
35
37

Channel 7

39

17
41

19

43

Channel 4

21

Channel 8

45

23
25

47
49

Comments:
Reference Documents:
Allen Bradley publication 1771-6.5.90

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 100 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Controller Tag ID No.

Allen Bradley Remote I/O Adapter


1771-ASB
PLC CIP

Location

Rack 2, Left most slot, CP-01

Equipment Name

Jumper / Dip Switch


Configuration
SW1

Actual

See Below

Open/Off
Closed/On
1

SW2

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Open/Off
Closed/On

Comments:
Reference Documents:
Allen Bradley publication 1771-2.48

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 101 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Controller Tag ID No.

Allen Bradley Remote I/O Adapter


1771-ASB
Remote PLC

Location

Rack 4, Left most slot, CP-01

Equipment Name

Jumper / Dip Switch


Configuration
SW1

Actual

See Below

Open/Off
Closed/On
1

SW2

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Open/Off
Closed/On

Comments:
Reference Documents:
Allen Bradley publication 1771-2.48

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 102 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Actual

Controller Tag ID No.

Allen Bradley Analog Input Module


1771-IFE
Remote PLC

Location

Rack 5, Group 7, CP-01A

Equipment Name

Jumper / Dip Switch


Configuration
Last State Jumpers
Channel 1

Channel 2

See Below
Verify / Date

1
3

Last State Jumpers


Channel 5

29

31

11

Channel 6

13

Channel 3

27

15

Verify / Date

33
35
37

Channel 7

39

17
41

19

43

Channel 4

21

Channel 8

45

23
25

47
49

Comments:
Reference Documents:
Allen Bradley publication 1771-6.5.90

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 103 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Controller Tag ID No.

Allen Bradley Remote I/O Adapter


1771-ASB
Remote PLC

Location

Rack 6, left most slot, CP-01A

Equipment Name

Jumper / Dip Switch


Configuration
SW1

Actual

See Below

Open/Off
Closed/On
1

SW2

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Open/Off
Closed/On

Comments:
Reference Documents:
Allen Bradley publication 1771-2.48

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 104 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Actual

Controller Tag ID No.

Allen Bradley Analog Input Module


1771-IFE
Remote PLC

Location

Rack 7, Group 7, CP-01A

Equipment Name

Jumper / Dip Switch


Configuration
Last State Jumpers
Channel 1

Channel 2

See Below
Verify / Date

1
3

Last State Jumpers


Channel 5

29

31

11

Channel 6

13

Channel 3

27

15

Verify / Date

33
35
37

Channel 7

39

17
41

19

43

Channel 4

21

Channel 8

45

23
25

47
49

Comments:
Reference Documents:
Allen Bradley publication 1771-6.5.90

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 105 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Controller Tag ID No.

Allen Bradley Remote I/O Adapter


1771-ASB
Remote PLC

Location

Rack 10, left most slot, CP-01A

Equipment Name

Jumper / Dip Switch


Configuration
SW1

Actual

See Below

Open/Off
Closed/On
1

SW2

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Open/Off
Closed/On

Comments:
Reference Documents:
Allen Bradley publication 1771-2.48

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 106 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 12, Group 0

Location

Area CP-5-010

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 107 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 12, Group 4

Location

Area Interstitial, CP-5-08

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 108 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 12, Group 6

Location

Area Interstitial, CP-5-08

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 109 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 13, Group 0

Location

Area 103C, CP-5-02

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 110 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 13, Group 2

Location

Area CP-5-02

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 111 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 13, Group 4

Location

Area CP-5-01

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 112 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 13, Group 6

Location

Area CP-5-01

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 113 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 14, Group 0

Location

Area CP-5-05

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 114 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 14, Group 2

Location

Area CP-5-05

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 115 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 14, Group 4

Location

Area CP-5-06

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 116 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 14, Group 6

Location

Area CP-5-07

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 117 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 15, Group 0

Location

Area CP-5-03

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 118 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
HARDWARE CONFIGURATION VERIFICATION - JUMPERS
Document any jumper configurations for each major component. Verify all configurations in
accordance with the reference document(s). If specifications are available document source
information.

Hardware

Specified

Equipment Name

SMC Solenoid Bank

Controller Tag ID No.

Rack 15, Group 2

Location

Area CP-5-04

Jumper / Dip Switch


Configuration
Address SW

Actual

See Below
Off
On
1

2 3 4 5 6

7 8 9 10

2 3 4 5 6

7 8 9 10

Comments:
Reference Documents:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 119 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:020/00
I:020/00
FV-100 Valve Open Limit SW.
I:020/01
I:020/01
FV-100 Valve Closed Limit SW.
O:120/12
O:120/12
FV-100 Valve Command
I:020/02
I:020/02
FV-107 Valve Open Limit SW.
I:020/03
I:020/03
FV-107 Valve Closed Limit SW.
O:120/13
O:120/13
FV-107 Valve Command
I:020/12
I:020/12
FV-113 Valve Open Limit SW.
I:020/13
I:020/13
FV-113 Valve Closed Limit SW.
O:120/17
O:120/17
FV-113 Valve Command
I:021/02
I:021/02
FV-135 Valve Open Limit SW.
I:021/03
I:021/03
FV-135 Valve Closed Limit SW.
O:122/12
O:122/12
FV-135 Valve Command
I:021/04
I:021/04
FV-136 Valve Open Limit SW.
I:021/05
I:021/05
FV-136 Valve Closed Limit SW.
O:122/14
O:122/14
FV-136 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 120 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 - 16
Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:021/10
I:021/10
FV-139 Valve Open Limit SW.
I:021/11
I:021/11
FV-139 Valve Closed Limit SW.
O:124/00
O:124/00
FV-139 Valve Command
I:021/12
I:021/12
FV-140 Valve Open Limit SW.
I:021/13
I:021/13
FV-140 Valve Closed Limit SW.
O:124/01
O:124/01
FV-140 Valve Command
I:021/14
I:021/14
FV-208 Valve Open Limit SW.
I:021/15
I:021/15
FV-208 Valve Closed Limit SW.
O:124/02
O:124/02
FV-208 Valve Command
I:021/16
I:021/16
FV-209 Valve Open Limit SW.
I:021/17
I:021/17
FV-209 Valve Closed Limit SW.
O:124/03
O:124/03
FV-209 Valve Command
I:022/00
I:022/00
FV-210 Valve Open Limit SW.
I:124/01
I:124/01
FV-210 Valve Closed Limit SW.
O:122/04
O:122/04
FV-210 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 121 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:022/02
I:022/02
FV-214 Valve Open Limit SW.
I:022/03
I:022/03
FV-214 Valve Closed Limit SW.
O:124/05
O:124/05
FV-214 Valve Command
I:022/04
I:022/04
FV-215 Valve Open Limit SW.
I:022/05
I:022/05
FV-215 Valve Closed Limit SW.
O:124/06
O:124/06
FV-215 Valve Command
I:022/06
I:022/06
FV-217 Valve Open Limit SW.
I:022/07
I:022/07
FV-217 Valve Closed Limit SW.
O:124/07
O:124/07
FV-217 Valve Command
I:022/10
I:022/10
FV-218 Valve Open Limit SW.
I:022/11
I:022/11
FV-218 Valve Closed Limit SW.
O:124/08
O:124/08
FV-218 Valve Command
I:022/12
I:022/12
FV-222 Valve Open Limit SW.
I:022/13
I:022/13
FV-222 Valve Closed Limit SW.
O:124/11
O:124/11
FV-222 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 122 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:023/04
I:023/04
FV-236 Valve Open Limit SW.
I:023/05
I:023/05
FV-236 Valve Closed Limit SW.
O:124/16
O:124/16
FV-236 Valve Command
I:023/06
I:023/06
FV-237 Valve Open Limit SW.
I:023/07
I:023/07
FV-237 Valve Closed Limit SW.
O:124/17
O:124/17
FV-237 Valve Command
I:023/10
I:023/10
FV-239 Valve Open Limit SW.
I:023/11
I:023/11
FV-239 Valve Closed Limit SW.
O:126/04
O:126/04
FV-239 Valve Command
I:023/12
I:023/12
FV-240 Valve Open Limit SW.
I:023/13
I:023/13
FV-240 Valve Closed Limit SW.
O:126/02
O:126/02
FV-240 Valve Command
I:023/14
I:023/14
FV-241 Valve Open Limit SW.
I:023/15
I:023/15
FV-241 Valve Closed Limit SW.
O:126/00
O:126/00
FV-241 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 123 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:043/14
I:043/14
FV-601 Valve Open Limit SW.
I:043/15
I:043/15
FV-601 Valve Closed Limit SW.
O:130/00
O:130/00
FV-601 Valve Command
I:043/16
I:043/16
FV-603 Valve Open Limit SW.
I:043/17
I:043/17
FV-603 Valve Closed Limit SW.
O:130/01
O:130/01
FV-603 Valve Command
I:044/00
I:044/00
FV-604 Valve Open Limit SW.
I:044/01
I:044/01
FV-604 Valve Closed Limit SW.
O:130/02
O:130/02
FV-604 Valve Command
I:044/02
I:044/02
FV-605 Valve Open Limit SW.
I:044/03
I:044/03
FV-605 Valve Closed Limit SW.
O:130/03
O:130/03
FV-605 Valve Command
I:044/04
I:044/04
FV-606 Valve Open Limit SW.
I:044/05
I:044/05
FV-606 Valve Closed Limit SW.
O:130/04
O:130/04
FV-606 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 124 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:044/06
I:044/06
FV-607 Valve Open Limit SW.
I:044/07
I:044/07
FV-607 Valve Closed Limit SW.
O:130/05
O:130/05
FV-607 Valve Command
I:044/10
I:044/10
FV-608 Valve Open Limit SW.
I:044/11
I:044/11
FV-608 Valve Closed Limit SW.
O:130/15
O:130/15
FV-608 Valve Command
I:044/12
I:044/12
FV-609 Valve Open Limit SW.
I:044/13
I:044/13
FV-609 Valve Closed Limit SW.
O:134/00
O:134/00
FV-609 Valve Command
I:044/14
I:044/14
FV-610 Valve Open Limit SW.
I:044/15
I:044/15
FV-610 Valve Closed Limit SW.
O:130/06
O:130/06
FV-610 Valve Command
I:044/16
I:044/16
FV-612 Valve Open Limit SW.
I:044/17
I:044/17
FV-612 Valve Closed Limit SW.
O:130/07
O:130/07
FV-612 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 125 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:045/00
I:045/00
FV-613 Valve Open Limit SW.
I:045/01
I:045/01
FV-613 Valve Closed Limit SW.
O:130/10
O:130/10
FV-613 Valve Command
I:045/02
I:045/02
FV-614 Valve Open Limit SW.
I:045/03
I:045/03
FV-614 Valve Closed Limit SW.
O:130/11
O:130/11
FV-614 Valve Command
I:045/04
I:045/04
FV-615 Valve Open Limit SW.
I:045/05
I:045/05
FV-615 Valve Closed Limit SW.
O:130/12
O:130/12
FV-615 Valve Command
I:045/06
I:045/06
FV-616 Valve Open Limit SW.
I:045/07
I:045/07
FV-616 Valve Closed Limit SW.
O:130/13
O:130/13
FV-616 Valve Command
I:045/10
I:045/10
FV-617 Valve Open Limit SW.
I:045/11
I:045/11
FV-617 Valve Closed Limit SW.
O:130/14
O:130/14
FV-617 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 126 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

Description

As
Specified
Yes / No

Verified
By / Date

I:046/00
I:046/00
FV-627 Valve Open Limit SW.
I:046/01
I:046/01
FV-627 Valve Closed Limit SW.
O:150/13
O:150/13
FV-627 Valve Command
I:046/02
I:046/02
FV-628 Valve Open Limit SW.
I:046/03
I:046/03
FV-628 Valve Closed Limit SW.
O:150/12
O:150/12
FV-628 Valve Command
I:046/04
I:046/04
FV-629 Valve Open Limit SW.
I:046/05
I:046/05
FV-629 Valve Closed Limit SW.
O:134/04
O:134/04
FV-629 Valve Command
I:046/06
I:046/06
FV-630 Valve Open Limit SW.
I:046/07
I:046/07
FV-630 Valve Closed Limit SW.
O:134/05
O:134/05
FV-630 Valve Command
I:046/10
I:046/10
FV-631 Valve Open Limit SW.
I:046/11
I:046/11
FV-631 Valve Closed Limit SW.
O:130/16
O:130/16
FV-631 Valve Command
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 127 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

O:015:00
O:015:01
O:015:02
O:015:03
O:016:00
O:016:01

N12:235
N12:236
N12:237
N12:238
N12:205
N12:206

O:016:02

N12:207

Description

As
Specified
Yes / No

Verified
By / Date

Pump CIP-6 Speed Signal


Pump CIP-7 Speed Signal
Pump CIP-8 Speed Signal
NPW Valve Position Command
HE-1 Temp. Control Valve
CIP Tank 1 Temp. Control
Valve
CIP Tank 2 Temp. Control
Valve
Pump CIP-5 Speed Signal
Tank P16 Weight
Tank P17 Weight
TT-NPW Temperature

O:016:03
N12:208
I:017:00
N12:39
I:017:01
N12:40
I:017:02
N12:41
TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 128 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
INPUT/OUTPUT LIST AND POINTS VERIFICATION
I/O Module Type/Model No.: Allen Bradley PLC 5
I/O Module Description: Analog and Discrete Modules
I/O Module Location: Racks 0 Verify the following list of Input/Output signals to/from the control system by simulating and
verifying I/O signals. Describe the test method below. Note: Points denoted as Spare will be
verified to be not connected to a field device and not included in the control logic.

Hardware
Point

Software
Address

I:057:00
I:057:01
I:057:02
I:057:03
I:057:04
I:057:05
I:057:06
I:077:00
I:077:01
I:077:02
I:077:03

N12:89
N12:90
N12:91
N12:92
N12:93
N12:94
N12:95
N12:139
N12:140
N12:141
N12:142

Description
WIT-660
WIT-690
WIT-691
WIT-692
WIT-697
WIT-411
WIT-696
WIT-052
WIT-054
WIT-058
WIT-412

As
Specified
Yes / No

Verified
By / Date

Weight
Weight
Weight
Weight
Weight
Weigh
Weight
Weight
Weight
Weight
Weight

TEST METHOD:
1
Inputs were examined using the PLC5 Programming Software online.
2
Outputs were verified using the PLC5 Programming Software online and Forcing the
respective output. The device operation was then verified in the field.
COMMENTS:
A
See attachment A CIP/SIP System I/O Checklist
B
The above points are a portion of a 20% recheck of Attachment A.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 129 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
MAJOR HARDWARE COMPONENT VERIFICATION
Verify that major hardware components and computer related devices, such as control
panel, panel mounted devices, process I/O hardware, PLC, MMI, PC, printers,
communication Interface devices, etc., are installed in accordance with design specification
or vendor documents. Wiring will also be verified using the 20%/40%/100% option as
indicated by validation effort.
Item
No.

Hardware
Description

Manufacturer

Model No.

Serial
No.

Location

Verified
by/Date

Main PLC
enclosure

Remote PLC
enclosure

Kaye enclosure

Kaye enclosure

Kaye enclosure
CIP room

1
1

2
2

Comments:
1 See PRO-563-CQ Ancillary System Specification Verification section for specific information
on major components.
2 See IQ Controls Corporation As -Built drawings in Attachment D.

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 130 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Allen Bradley PLC Power Supply #1

Controller Tag ID No.:

PLC CIP
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

16 Amps

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-2

Circuit Breaker Location

CP-01, TB1

Actual

COMMENTS:
1

Located in Panel CP-01, Powerhouse.

REFERENCE DOCUMENT(S):
Allen Bradley I/O Chassis and Power Supplies Product Data Pub #1771-2.185

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 131 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Allen Bradley PLC Power Supply #2

Controller Tag ID No.:

PLC CIP
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

16 Amps

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-3

Circuit Breaker Location

CP-01, TB1

Actual

COMMENTS:
1

Located in Panel CP-01, Powerhouse.

REFERENCE DOCUMENT(S):
Allen Bradley I/O Chassis and Power Supplies Product Data Pub #1771-2.185

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 132 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Allen Bradley Panelview

Controller Tag ID No.:

Main OCS
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Frequency

60 Hertz 1

Circuit Breaker Number

CB-4

Circuit Breaker Location

CP-01, TB1

Actual

COMMENTS:
1

Located in Panel CP-01, Powerhouse.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 133 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Acopian 24 DC Power Supply

Controller Tag ID No.:

P1
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

15 Amps

Line Power

1200 W

Frequency

60 Hertz 1

Circuit Breaker Number

CB-6

Circuit Breaker Location

CP-01, TB1

Actual

COMMENTS:
1

This supplies the Discrete I/O and the SMC solenoid bank valves.

Located in Panel CP-01, Powerhouse.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 134 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Acopian 30 VDC Power Supply

Controller Tag ID No.:

P2
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

2 Amps

Line Power

210 W

Frequency

60 Hertz 1

Circuit Breaker Number

CB-5

Circuit Breaker Location

CP-01, TB1

Actual

COMMENTS:
1
2

This supplies the Analog I/O.


Located in Panel CP-01, Powerhouse.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 135 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Acopian 24 VDC Power Supply

Controller Tag ID No.:

P3
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

2 Amps

Line Power

210 W

Frequency

60 Hertz 1

Circuit Breaker Number

CB-7

Circuit Breaker Location

CP-01, TB1

Actual

COMMENTS:
1
2

This unit supplies the SMC solenoid bank electronics.


Located in Panel CP-01, Powerhouse.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 136 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Allen Bradley PLC Power Supply #3

Controller Tag ID No.:

Remote Rack
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

16 Amps

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-2

Circuit Breaker Location

CP-01A, TB1

Actual

COMMENTS:
1

Located in Panel CP-01A .

REFERENCE DOCUMENT(S):
Allen Bradley I/O Chassis and Power Supplies Product Data Pub #1771-2.185

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 137 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Allen Bradley PLC Power Supply #4

Controller Tag ID No.:

Remote Rack
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

16 Amps

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-3

Circuit Breaker Location

CP-01A, TB1

Actual

COMMENTS:
1

Located in Panel CP-01A .

REFERENCE DOCUMENT(S):
Allen Bradley I/O Chassis and Power Supplies Product Data Pub #1771-2.185

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 138 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Allen Bradley PLC Power Supply #5

Controller Tag ID No.:

PLC CIP
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

16 Amps

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-4

Circuit Breaker Location

CP-01A, TB1

Actual

COMMENTS:
1

Located in Panel CP-01A .

REFERENCE DOCUMENT(S):
Allen Bradley I/O Chassis and Power Supplies Product Data Pub #1771-2.185

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 139 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Acopian 24 VDC Power Supply

Controller Tag ID No.:

P4
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

15 Amps

Line Power

1500 W

Frequency

60 Hertz 1

Circuit Breaker Number

CB-6

Circuit Breaker Location

CP-01A, TB1

Actual

COMMENTS:
1

This supplies the Discrete I/O and the SMC solenoid bank valves.

Located in Panel CP-01 .

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 140 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Acopian 30 VDC Power Supply

Controller Tag ID No.:

P5
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

2 Amps

Line Power

210 W

Frequency

60 Hertz 1

Circuit Breaker Number

CB-5

Circuit Breaker Location

CP-01A, TB1

Actual

COMMENTS:
1

This supplies the Analog I/O.

Located in Panel CP-01A .

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 141 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Acopian 24 VDC Power Supply

Controller Tag ID No.:

P6
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

User Current Capacity

2 Amps

Line Power

210 W

Frequency

60 Hertz 1

Circuit Breaker Number

CB-7

Circuit Breaker Location

CP-01A, TB1

Actual

COMMENTS:
1

This supplies the SMC solenoid bank electronics.

Located in Panel CP-01A .

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 142 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Kaye Digistrip 4S-Plus Microprocessor Recorder

Controller Tag ID No.:

CP-02
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-2

Circuit Breaker Location

CP-02

Actual

COMMENTS:
1

Located in Area 1.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 143 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Kaye Digistrip 4S-Plus Microprocessor Recorder

Controller Tag ID No.:

CP-05
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-2

Circuit Breaker Location

CP-05

Actual

COMMENTS:
1

Located in Area 1036.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 144 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Kaye Digistrip 4S-Plus Microprocessor Recorder

Controller Tag ID No.:

CP-22
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-2

Circuit Breaker Location

CP-22

Actual

COMMENTS:
1

Located in Panel CP-22, Powerhouse.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 145 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Nematron Operator Terminal

Controller Tag ID No.:

Remote OCS CP-07


Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

EDP2-2 #7

Circuit Breaker Location

Interstitial Above 1089

Actual

COMMENTS:
1

Located in Area 2.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 146 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Nematron Operator Terminal

Controller Tag ID No.:

Remote OCS CP-04


Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

ERP2-1B #15

Circuit Breaker Location

Interstitial Northeast

Actual

COMMENTS:
1

Located in .

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 147 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Nematron Operator Terminal

Controller Tag ID No.:

Remote OCS CP-TT-07


Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

ERP2-1B #16

Circuit Breaker Location

Interstitial Northeast

Actual

COMMENTS:
1

Located in Area 1078.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 148 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Nematron Operator Terminal

Controller Tag ID No.:

Remote OCS CP-03


Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

ERP2-1B #13

Circuit Breaker Location

Interstitial Northeast

Actual

COMMENTS:
1

Located in Area 1034.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 149 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Nematron Operator Terminal

Controller Tag ID No.:

Remote OCS
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-3

Circuit Breaker Location

CP-02

Actual

COMMENTS:
1

Located in Area 1.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 150 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Nematron Operators Terminal

Controller Tag ID No.:

CP-05
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Circuit Breaker Number

CB-3

Circuit Breaker Location

CP-05

Actual

COMMENTS:
1

Located in Area 1036.

REFERENCE DOCUMENT(S):

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 151 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
UTILITIES-ELECTRICAL
Confirm that the utilities necessary for the operation of the components of the control system have
been installed in accordance with design and/or manufacturing specifications.
Component Name:

Nematron Operators Terminal

Controller Tag ID No.:

CP-07
Specified1

Electrical System
Line Voltage

120 VAC 10%

Phase

Single Phase

Line Power

Not Specified

Frequency

60 Hertz 1

Actual

Circuit Breaker Number


Circuit Breaker Location
COMMENTS:
1

Located in Lyo Mechanical Area 2.

REFERENCE DOCUMENT(S):

Verified By: __________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 152 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SUPPLY VOLTAGE AND CIRCUIT PROTECTION VERIFICATION
Verify that the supply voltage to the control system is installed in accordance with the
manufacturers specifications. Record the location of voltage measurement and the actual
value.
Page 1 of 2
COMPONENT SUPPLY VOLTAGE
Location of
Voltage
Measurement

Specified
Result

Panelview Main
OCS

CP-01

120 VAC

Nematron
Operator
Terminal

CP-02

Nematron
Operator
Terminal

CP-03

Nematron
Operator
Terminal

CP-04

Nematron
Operator
Terminal

CP-05

Device Name

Actual
Result

Performed By /
Date:

+/- 10%
120 VAC
+/- 10%
120 VAC
+/- 10%
120 VAC
+/- 10%
120 VAC
+/- 10%

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 153 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SUPPLY VOLTAGE AND CIRCUIT PROTECTION VERIFICATION
Verify that the supply voltage and circuit protection devices associated with the control
system are installed in accordance with the manufacturer specifications. Verify the
amperage and/or voltage of the protection device.
Page 2 of 2
COMPONENT SUPPLY VOLTAGE
Location of
Voltage
Measurement

Specified
Result

Nematron
Operator
Terminal

CP-TT-07
Suite 300

120 VAC

Nematron
Operator
Terminal

CP-07
Suite 400

120 VAC

Main PLC
enclosure CP-01

CP-01
Powerhouse

120 VAC

Remote PLC
enclosure
CP-01A

CP-01A
Suite 400

120 VAC

Device Name

Actual
Result

Performed By /
Date:

+/- 10%

+/- 10%

+/- 10%

+/- 10%

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 154 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SOFTWARE COMPONENT VERIFICATION
Verify the following information about the installed software and source code for the specified
equipment. Document and comment on any noticeable deviations.
Equipment Name/Description:
Equipment ID No.:
Item

Kaye Validator
Digistrip 4 Plus , CP-02

Specified

Title

Validator Programmer
Software

Version

Not Specified

Date:

Not Specified

Location

Not Specified

Filename

Not Specified

Development
Software Used

Not Specified

Disk Copy

Installed Copy

Does the Installed Version Identification Disk Version Identification = Hardcopy Version
Identification?
YES / NO
COMMENTS:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 155 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SOFTWARE APPLICATION CODE VERIFICATION
ID No.: Control Coprocessor CP-01
Verify the current software source code and the internal change control procedure by contacting the
appropriate person. Ensure the current software is installed and implemented win accordance with the
applicable specifications. Obtain a printout of a program listing and/or batch files for comparison as
required.
Department contacted for Information on Application Source Code:
Name

Engineering Department

Company

Big Pharma

Software Source Code:


Manufacturer/Company Name

IQ Controls Corporation

Version/Date

March 27, 1996

Storage Location

Maintenance, Validation Files

Internal Change Control Procedure


Title/Name

Authorization SOP

Number
Version/Date
Storage Location
COMMENTS:

Verified By: ____________________________________________

Date: _____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 156 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SOFTWARE APPLICATION CODE VERIFICATION
ID No.: Main OCS
Verify the current software source code and the internal change control procedure by contacting the
appropriate person. Ensure the current software is installed and implemented win accordance with the
applicable specifications. Obtain a printout of a program listing and/or batch files for comparison as
required.
Department contacted for Information on Application Source Code:
Name

Engineering Department

Company

Big Pharma

Software Source Code:


Manufacturer/Company Name

IQ Controls Corporation

Version/Date

October 29, 1996

Storage Location

Maintenance, Validation Files

Internal Change Control Procedure


Title/Name

Authorization SOP

Number
Version/Date
Storage Location
COMMENTS:

Verified By: ____________________________________________

Date: _____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 157 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

Approach Remote
Operator Station at
CP-02,

From CIP System Idle


screen, Press Menu

Select Start CIP

Password Required screen appears

Enter an invalid
password, press
Enter

Returns user to Menu screen

Select Start CIP

Password Required screen appears

Enter a valid operator


password, press
Enter

None

Menu screen appears

Change Circuit screen appears

COMMENTS:
1

Steps 1-6 verify the basic, operator level, security. .

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 158 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

Select a circuit, press


Enter

Change Wash Type screen appears

Choose Select
Options, press Enter

Password Required screen appears

Enter a valid operator


level password, press
Enter

Returns to Change Wash Type screen

10

Choose Select
Options, press Enter

Password Required screen appears

11

Enter a valid
supervisory level
password, press
Enter

Select Mode Select Cycles screen


appears

12

Test is complete,
press Cancel three
times.

CIP System Idle screen appears

COMMENTS:
1

Steps 7-12 verify the basic, operator level, security. .

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 159 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

13

Approach Remote
Operator Station at
CP-03,

14

From CIP System Idle


screen, Press Menu

15

Select Start CIP

Password Required screen appears

16

Enter an invalid
password, press
Enter

Returns user to Menu screen

17

Select Start CIP

Password Required screen appears

18

Enter a valid operator


password, press
Enter

None

Menu screen appears

Change Circuit screen appears

COMMENTS:
1

Steps 13-18 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 160 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

19

Select a circuit, press


Enter

Change Wash Type screen appears

20

Choose Select
Options, press Enter

Password Required screen appears

21

Enter a valid operator


level password, press
Enter

Returns to Change Wash Type screen

22

Choose Select
Options, press Enter

Password Required screen appears

23

Enter a valid
supervisory level
password, press
Enter

Select Mode Select Cycles screen


appears

24

Test is complete,
press Cancel three
times.

CIP System Idle screen appears

COMMENTS:
1

Steps 19-24 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 161 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

25

Approach Remote
Operator Station at
CP-04, Suite 100

26

From CIP System Idle


screen, Press Menu

27

Select Start CIP

Password Required screen appears

28

Enter an invalid
password, press
Enter

Returns user to Menu screen

29

Select Start CIP

Password Required screen appears

30

Enter a valid operator


password, press
Enter

None

Menu screen appears

Change Circuit screen appears

COMMENTS:
1

Steps 25-30 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 162 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

31

Select a circuit, press


Enter

Change Wash Type screen appears

32

Choose Select
Options, press Enter

Password Required screen appears

33

Enter a valid operator


level password, press
Enter

Returns to Change Wash Type screen

34

Choose Select
Options, press Enter

Password Required screen appears

35

Enter a valid
supervisory level
password, press
Enter

Select Mode Select Cycles screen


appears

36

Test is complete,
press Cancel three
times.

CIP System Idle screen appears

COMMENTS:
1

Steps 31-36 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 163 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

37

Approach Remote
Operator Station at
CP-05, Suite 200

38

From CIP System Idle


screen, Press Menu

39

Select Start CIP

Password Required screen appears

40

Enter an invalid
password, press
Enter

Returns user to Menu screen

41

Select Start CIP

Password Required screen appears

42

Enter a valid operator


password, press
Enter

None

Menu screen appears

Change Circuit screen appears

COMMENTS:
1

Steps 37-42 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 164 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

43

Select a circuit, press


Enter

Change Wash Type screen appears

44

Choose Select
Options, press Enter

Password Required screen appears

45

Enter a valid operator


level password, press
Enter

Returns to Change Wash Type screen

46

Choose Select
Options, press Enter

Password Required screen appears

47

Enter a valid
supervisory level
password, press
Enter

Select Mode Select Cycles screen


appears

48

Test is complete,
press Cancel three
times.

CIP System Idle screen appears

COMMENTS:
1

Steps 43-48 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 165 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

49

Approach Remote
Operator Station at
CP-TT-07, Suite 300

50

From CIP System Idle


screen, Press Menu

51

Select Start CIP

Password Required screen appears

52

Enter an invalid
password, press
Enter

Returns user to Menu screen

53

Select Start CIP

Password Required screen appears

54

Enter a valid operator


password, press
Enter

None

Menu screen appears

Change Circuit screen appears

COMMENTS:
1

Steps 49-54 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 166 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

55

Select a circuit, press


Enter

Change Wash Type screen appears

56

Choose Select
Options, press Enter

Password Required screen appears

57

Enter a valid operator


level password, press
Enter

Returns to Change Wash Type screen

58

Choose Select
Options, press Enter

Password Required screen appears

59

Enter a valid
supervisory level
password, press
Enter

Select Mode Select Cycles screen


appears

60

Test is complete,
press Cancel three
times.

CIP System Idle screen appears

COMMENTS:
1

Steps 55-60 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 167 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

61

Approach Remote
Operator Station at
CP-07, Suite 400

62

From CIP System Idle


screen, Press Menu

63

Select Start CIP

Password Required screen appears

64

Enter an invalid
password, press
Enter

Returns user to Menu screen

65

Select Start CIP

Password Required screen appears

66

Enter a valid operator


password, press
Enter

None

Menu screen appears

Change Circuit screen appears

COMMENTS:
1

Steps 61-66 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 168 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SECURITY CODE TEST
Verify that the program security prevents unauthorized access to process screens and PID parameter
changes. Obtain the current password from Maintenance and record the current password in the
comments section.
Step
No.

Test Procedure

Specified Result

Actual Result

67

Select a circuit, press


Enter

Change Wash Type screen appears

68

Choose Select
Options, press Enter

Password Required screen appears

69

Enter a valid operator


level password, press
Enter

Returns to Change Wash Type screen

70

Choose Select
Options, press Enter

Password Required screen appears

71

Enter a valid
supervisory level
password, press
Enter

Select Mode Select Cycles screen


appears

72

Test is complete,
press Cancel three
times.

CIP System Idle screen appears

COMMENTS:
1

Steps 67-72 verify the basic, operator level, security.

See IQ Controls Corporation CIP/SIP System, Editors Manual for instructions on how to change/add
passwords.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 169 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

Approach Remote
Operator Control
Station at CP-02,

From CIP System Idle


screen, press Menu

Select Start CIP

Enter a valid operator


password, press
Enter

Select
FTESTNCY.PIN,
press Enter

Select Standard CIP,


press Enter

Press Enter

Specified Result

Actual Result

None

Menu screen appears


Password Required screen appears
Change Circuit screen appears

Change Wash Type screen appears

Enter to confirm screen appears


FTESTNCY.PIN
Standard CIP
After a delay, Program is to Function
Test 1037 CIP/SIP message appears

Reference Document and No.: Inc. CIP/SIP System Functional Design Document.
COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 170 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

Specified Result

Actual Result

Press Enter

After a delay, Connect a hose and man.


valve message appears

Press Enter

After a delay, Ensure Man. Valve closed


message appears

10

Press Enter

After a delay, Install hose on CIPS-2


message appears.

11

Press Enter

12

Press Menu

13

Select Change Mode

After a delay, FV-056 is open and


042>30 gpm

FT-

Menu choices screen appears


F1-Run F2-Hold On F3-Halt F4-Hold Off
screen appears

Reference Document and No.: Inc. CIP/SIP System Functional Design Document.
COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 171 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

14

Select Hold Off

15

Press Cancel

Specified Result

Actual Result

FT-042 goes to zero and FV-056 closes


Screen displays:
Step-005
Time xx:xx
off
Mode-Hold off

Hold

16

Press Menu

17

Select Change Mode

18

Select Run

19

Press Cancel

Screen displays:
Step-005
Time xx:xx
Hold off
Mode-Run
The time displayed will be counting down.

20

Time displayed
reaches 00:00

Screen displays:
Step-006
Time xx:xx
Hold on
Mode-Run
Also: FV-056 is open, FT-042 > 30 gpm
Timer is counting down.

21

Press Menu

22

Select Change Mode

Menu Choices screen appears


F1-Run F2-Hold On F3-Halt F4-Hold Off
screen appears
FT-042 > 30 gpm, FV-056 opens
Menu Choices screen appears

Menu Choices screen appears


F1-Run F2-Hold On F3-Halt F4-Hold Off
screen appears

Reference Document and No.: Inc. CIP/SIP System Functional Design Document.
COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 172 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

Specified Result

Actual Result

23

Select Hold on

24

Press Cancel

25

Press Menu

26

Select Change Mode

27

Select Run

28

Press Cancel

29

Timer = 00:00

Message Hold on/off are finished


Starting F4 tests

30

Press Enter

After delay, FV-056 open, FT-042 >30 gpm

Menu Choice screen appears


Screen displays:
Step-006
Time xx:xx
Hold on
Mode-Run
Also: FV-056 is open, FT-042 > 30 gpm
Timer is not counting down.
Menu Choices screen appears
F1-Run F2-Hold On F3-Halt F4-Hold Off
screen appears
Menu Choices screen appears
After a delay, screen displays:
Step-007
Time xx:xx
Mode-Run
Also: FV-056 is open, FT-042 > 30 gpm
Timer is counting down

Reference Document and No.: Inc. CIP/SIP System Functional Design Document.
COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 173 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

31

Press F4 key on
front of panel

32

Press Cancel

33

Select Cancel
Note: Mode=Hold off

Specified Result

Actual Result

FV-056 is closed, FT-042 = 0


F1-Run F2-Hold On F3-Halt F4-Hold Off
screen appears
Menu Choices screen appears
Screen displays:
Step-008
Mode-Hold off

Time xx::xx

34

Press Menu

35

Select Change mode

36

Select Run

37

Press Cancel
Note: Mode=Run

Screen displays:
Step-008
Mode-Run

38

Timer=00:00

After a delay, F4 Test finished message


displays

39

Press Enter

FV-056 opens, FT-042 > 30 gpm


Timer begins timing

40

Timer=00:00

FV-056 closes, FT-042 = 0


Time test done message appears

Menu Choices screen appears


F1-Run F2-Hold On F3-Halt F4-Hold Off
screen appears
FV-056 opens, FT-042 = > 30 gpm
Time xx::xx

Reference Document and No.: Inc. CIP/SIP System Functional Design Document.
COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 174 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

Specified Result

Actual Result

41

Press Enter

Tanks begin filling

42

Timer=00:00

Press Enter to Start Temp. test appears

43

In Room 1038,
remove TT-043 probe
from piping and put in
cool water

44

Press Enter

45

Press Enter

46

Put TT-043 in hot


water

47

Press Enter

When TT-043 > 70 c, screen should


display Temp. test finished message

48

Press Enter

Tank will fill for next test message


appears

TT-043 < 70 c

Screen displays:
Step-013
Time xx::xx
Mode-Run
Timer is not timing.
Program does not advance.
Event error TT-043 too low displays
TT-043 > 70 c

Reference Document and No.: Inc. CIP/SIP System Functional Design Document.
COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 175 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

Specified Result

Actual Result

49

Reinstall TT-043 into


pipe

50

Press Enter

Tank P3 begins filling. FV-056 opens.

51

Timer=00:00

Press enter to start flow test


Ensure man. Valve is closed message
displays

52

Press Enter

53

Press Enter

54

Open manual valve


Observe FT-042 climb

55

Press Enter

Message Flow test finished displays

56

Press Enter

Tank will fill message appears

57

Press Enter

Tank P3 begins filling

58

Timer=00:00

Start conductivity screen appears

Reference Document and No.:

Screen displays:
Step-017
Time xx::xx
Mode-Run
Timer is not timing.
Program does not advance.
Event error FT-042 is too low displays
FT-042 > 5.0 gpm

CIP/SIP System Functional Design Document.

COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 176 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
FUNCTIONAL TEST VERIFICATION
Verify system operation by following the steps and associated test procedures in order. Verify the
descriptions for each step and verify that the system operation is in accordance with the specified
result.
Step
No.

Test Procedure

Specified Result

59

In room 1038, remove


CT-041 probe from
piping and put in high
conductivity solution.

CT-041 > 5.0 S

60

Press Enter

61

Press Enter

62

Put CT-041 back into


piping. Open manual
valve. Press Enter

63

Press Enter

Reference Document and No.:

Actual Result

Screen displays:
Step-021
Time xx::xx
Mode-Run
Timer is not timing.
Program does not advance.
CIT-041 too high Event error displays
CT-041 begins to decrease. When CT-041
< 5.0 S, message Cond.test finished
appears
CIP System Idle screen appears
CIP/SIP System Functional Design Document.

COMMENTS:
Note: For Area 2, Freeze dryer only.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 177 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

CR-117
Not
verified

At MCC2-1, turn manual


selector switch for CIP-1
to on for 10 seconds

Panelview displays alarm.


CIP batch printer prints
alarm.

CR-118
Not
verified

At MCC2-1, turn manual


selector switch for CIP-2
to on for 10 seconds

Panelview displays alarm.


CIP batch printer prints
alarm.

CR-119
Not
verified

At MCC2-1, turn manual


selector switch for CIP-3
to on for 10 seconds

Panelview displays alarm.


CIP batch printer prints
alarm.

CR-120
Not
verified

At MCC2-1, turn manual


selector switch for CIP-4
to on for 10 seconds

Panelview displays alarm.


CIP batch printer prints
alarm.

CR-037
Not
verified

At MCC1-1, turn manual


selector switch for CIP-9
to on for 10 seconds

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:
1

MCC2-1 is on Powerhouse

MCC1-1 is on Interstitial southeast area

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 178 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

CR-652
Not
verified

At MCC1-1, turn manual


selector switch for CIP10 to on for 10 seconds

Panelview displays alarm.


CIP batch printer prints
alarm.

CR-533
Not
verified

At MCC1-1, turn manual


selector switch for CIP11 to on for 10 seconds

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-001
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-002
Failed to
proof

Actuate valve close


limit switch while valve
output is not active. 1

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-003
Failed to
proof

Actuate valve close


limit switch while valve
output is not active. 1

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-004
Failed to
proof

Actuate valve close


limit switch while valve
output is not active. 1

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:
1

N.O. valve

MCC1-1 is on Interstitial southeast area

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 179 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-005
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-006
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-007
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-008
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-009
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-010
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 180 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-011
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-012
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-013
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-014
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-015
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-016
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 181 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-017
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-018
Failed to
proof

Actuate valve close


limit switch while valve
output is not active. 1

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-019
Failed to
proof

Actuate valve close


limit switch while valve
output is not active. 1

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-020
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-021
Failed to
proof

Actuate valve close


limit switch while valve
output is not active. 1

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-022
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:
1

N.O. valve

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 182 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-023
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-024
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-025
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-029
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-030
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-031
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 183 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-032
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-055
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-056
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-057
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-100
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-107
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 184 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-108
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-109
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-110
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-112
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-113
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-134
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 185 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-135
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-136
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-137
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-138
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-139
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-140
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Actual Result

Verified
By / Date

COMMENTS:

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 186 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

FV-690
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

FV-691
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.


CIP batch printer prints
alarm.

Problem
reading
diskette

With no disk in
coprocessor, press
upload on panelview
supervisor screen

Panelview displays alarm..

SV-028
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.

SV-230
Failed to
proof

Actuate valve open


limit switch while valve
output is not active.

Panelview displays alarm.

Actual Result

Verified
By / Date

COMMENTS:
1

All alarms are time and date stamped.

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 187 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

Thornton
Gateway
1:128
failed

Disconnect TNET-01-01
from coprocessor
stopping communication
with Gateway 1:128

Panelview displays alarm.


Batch printer prints alarm.

Thornton
Gateway
1:129
failed

Disconnect TNET-01-02
from coprocessor
stopping communication
with Gateway 1:129

Panelview displays alarm.


Batch printer prints alarm.

Thornton
Network
#1 failed

Disconnect both TNET01 cables from


coprocessor

Panelview displays alarm.


Batch printer prints alarm.
Robertshaw DMS receives
CIP alarm.

Thornton
Gateway
2:128
failed

Disconnect TNET-02-01
from coprocessor
stopping communication
with Gateway 2:128

Panelview displays alarm.


Batch printer prints alarm.

Thornton
Gateway
2:129
failed

Disconnect RS-232EX
from coprocessor
stopping communication
with Gateway 2:129

Panelview displays alarm.


Batch printer prints alarm.

Thornton
Network
#2 failed

Disconnect both cables


for Gateway 2:128 and
2:129 from coprocessor

Panelview displays alarm.


Batch printer prints alarm.
Robertshaw DMS receives
CIP alarm.

Actual Result

Verified
By / Date

COMMENTS:
1

All alarms are time and date stamped.

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 188 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

Thornton
xmtter
1:21
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmtter
1:22
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:23
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:31
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:32
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:41
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Actual Result

Verified
By / Date

COMMENTS:
1

All alarms are time and date stamped.

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 189 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

Thornton
xmtter
1:42
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmtter
1:71
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:72
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:73
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:74
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Thornton
xmitter
1:75
failed

Disconnect TNET wire


from each particular
transmitter

Panelview displays alarm.


Batch printer prints alarm.

Actual Result

Verified
By / Date

COMMENTS:
1

All alarms are time and date stamped.

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 190 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ALARM VERIFICATION
Verify that all device alarms controlled by the application logic are identified correctly, function
properly, and respond in accordance with the manufacturers specifications.
Test Description
Verification will be completed by creating specific alarm conditions and verifying the correct alarm
output is energized. For each alarm, document the test procedure used to activate the alarm and
the logic response to the alarm (if applicable). Record verification of the alarm annunciation alarm
acknowledge, and alarm reset for each alarm condition.
Alarm

Test Procedure

Specified Result

A remote
OCS failed
to respond

While running cycle,


disconnect power from
remote OCS

Panelview displays alarm.


Batch printer prints alarm.

Main seq
exceeded
max time
in step

While running cycle,


disconnect power from
remote OCS

Panelview displays alarm.


Batch printer prints alarm.

Lyo seq
exceeded
max time
in step

While running cycle,


disconnect power from
remote OCS

Panelview displays alarm.


Batch printer prints alarm.

General
PLC rack
failure

In CP-01 turn off rack 2


power supply

Panelview displays alarm.


Batch printer prints alarm.
Robertshaw DMS
receives CIP alarm

SMC
solenoid
bank rack
failure

In any CP-S panel


remove power from
SMC valve solenoid
bank

Panelview displays alarm.


Batch printer prints alarm.

Panelview
has rack
faulted

Disconnect Blue hose


remote I/O cable to CIP
panelview

Panelview displays alarm.


Batch printer prints alarm.
Robertshaw DMS
receives CIP alarm

Actual Result

Verified
By / Date

COMMENTS:
1

All alarms are time and date stamped.

Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 191 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
POWER FAILURE TEST
Verify that each specified operation of the operator display panel accuracy performs the specified
function in accordance with the manufacturer specifications.

Step No.

Test Method

Specified Results

In Area 1 at CP-02 start


FTESTCY.PIN program.
When it is running, go to
Panel CP-01 in Powerhouse
and open circuit breakers
CB-2, CB-3. This powers off
the PLC.

In Area 1 at CP-02 start


FTESTCY.PIN program.
When it is running open
panel CP-02 and open circuit
breaker CB-3 removing
power from remote operator
control station.

Removes power from the


PLC, all devices are in failsafe mode. When power is
restored, the PLC restarts
the program safely or
returns to an initial
condition may restart the
operation.
During the power failure to
the operator display panel,
all devices are in a fail safe
mode. When power is
restored, the operator
display panel restarts
normally and returns to an
initial condition where the
operator may restart the
operation.

Actual Results

COMMENTS:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 192 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
POWER FAILURE TEST
Verify that each specified operation of the operator display panel accuracy performs the specified
function in accordance with the manufacturer specifications.

Step No.

Test Method

Specified Results

With program
FTESTLYO.PIN running at
CP-07 in Area 2, go to CP-01
on Powerhouse and remove
power from control
coprocessor only.

With program
FTESTLYO.PIN running at
CP-07 in Area 1, go to CP-01
on Powerhouse and open
circuit breaker CB-4

Removes power to the


coprocessor all devices are
in fail-safe mode. When
power is restored, the
coprocessor restarts the
program safely or returns to
an initial condition may
restart the operation.
During the power failure to
the operator display panel,
all devices are in a fail safe
mode. When power is
restored, the operator
display panel restarts
normally and returns to an
initial condition where the
operator may restart the
operation.

Actual Results

COMMENTS:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 193 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ENVIRONMENTAL OPERATING PARAMETERS VERIFICATION
Verify that the environmental parameters (such as temperatures and relative humidity) within the
panels and/or cabinets where the controllers reside, are within the manufacturers specifications.
Temperature
Location

Controller

Internal to CP-01
Powerhouse

Allen-Bradley
PLC 5

Internal to CP-01
Powerhouse

Allen-Bradley
Panelview

CP-02 Area 1

Kaye printer/
recorder

CP-05 Area 2

Kaye printer/
recorder

Specified
0-60
degrees
Celsius
0-50
degrees
Celsius
0-50
degrees
Celsius
0-40
degrees
Celsius

Relative Humidity

Actual

Specified

Actual

Verified
By/Date

5-95% w/o
condensing
95% @ 0-30 C
75% @ 30-40 C
40% @ 40-50 C
95% noncondensing
90% RH or less
w/o
condensing

COMMENTS:
Reference documents: Allen-Bradley Publications 1784-1.10, dated May 1991; Allen-Bradley
Publication 2711.1.1, dated September 1992.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 194 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
ENVIRONMENTAL OPERATING PARAMETERS VERIFICATION
Verify that the environmental parameters (such as temperatures and relative humidity) within the
panels and/or cabinets where the controllers reside, are within the manufacturers specifications.
Temperature
Location

Controller

Internal to CP-22
Powerhouse

Kaye Printer
Recorder

Internal to
CP-01A
Area 3

1771-ASB
Remote I/O
Adapter

Specified
0-60
degrees
Celsius
0-50
degrees
Celsius

Relative Humidity

Actual

Specified

Actual

Verified
By/Date

5-95% w/o
condensing
95% @ 0-30 C
75% @ 30-40 C
40% @ 40-50 C

COMMENTS:
Reference documents: Allen-Bradley Publications 1784-1.10, dated May 1991; Allen-Bradley
Publication 2711.1.1, dated September 1992.

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 195 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
TEST EQUIPMENT
List all testing equipment used during the Controller Qualification testing.

Test Equipment Type


Multimeter

Model No.

Variables
Measured

Serial No.

Digital Volt Meter

Voltage, Amps,
Resistance
Volts/Amperes

Temperature/RH Meter

Temperature/RH

Calibration
Exp. Date

COMMENTS:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 196 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.

Drawing Title

Main PLC
Main PLC Enclosure Layout
Sheet 1 of 23
Main PLC
Main PLC Panel Layout
Sheet 2 of 23
Main PLC
I/O Chassis Detail Rack 0 & 1
Sheet 3 of 23
Main PLC
I/O Chassis Detail Rack 2 & 3
Sheet 4 of 23
Main PLC
Terminal Block Layout - Rail 1
Sheet 5 of 23
Main PLC
Terminal Block Layout - Rail 3
Sheet 6 of 23
Main PLC
Terminal Block Layout - Rail 2 & 4
Sheet 7 of 23
Main PLC
Power Distribution (Main) 120 VAC
Sheet 8 of 23
Main PLC
Power Distribution (Main) 24 VDC
Sheet 9 of 23
Main PLC
Power Distribution (Main) 24 VDC
Sheet 10 of 23
Main PLC
Power Distribution (Main) 24 VDC
Sheet 11 of 23
Main PLC
Main Enclosure Rack 1, Group 4
Sheet 12 of 23
Storage Location: Validation Files

Revision
No.

Date

Original

1/27/06

6/10/06

6/10/06

Original

1/27/06

2/10/06

Original

1/31/06

Original

1/31/06

Original

1/31/06

Original

1/27/06

2/10/06

2/10/06

2/10/06

Verified
By / Date

Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 197 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.

Drawing Title

Main PLC
Main Enclosure Rack 1, Group 5
Sheet 13 of 23
Main PLC
Main Enclosure Rack 1, Group 6
Sheet 14 of 23
Main PLC
Main Enclosure Rack 1, Group 7
Sheet 15 of 23
Main PLC
Main Enclosure Rack 2, Group 0
Sheet 16 of 23
Main PLC
Main Enclosure Rack 2, Group 1
Sheet 17 of 23
Main PLC
Main Enclosure Rack 2, Group 2
Sheet 18 of 23
Main PLC
Main Enclosure Rack 2, Group 3
Sheet 19 of 23
Main PLC
Main Enclosure Rack 2, Group 4
Sheet 20 of 23
Main PLC
Main Enclosure Rack 2, Group 5
Sheet 21 of 23
Main PLC
Main Enclosure Rack 3, Group 0
Sheet 22 of 23
Main PLC
Main Enclosure Rack 3, Group 1
Sheet 23 of 23
Storage Location: Validation Files

Revision
No.

Date

2/10/06

2/10/06

Original

1/27/06

6/14/06

6/14/06

6/14/06

6/14/06

6/14/06

2/10/06

6/14/06

2/10/06

Verified
By / Date

Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 198 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.

Drawing Title

Remote PLC
Remote PLC Enclosure Layout
Sheet 1 of 44
Remote PLC
Remote Panel Layout
Sheet 2 of 44
Remote PLC
I/O Chassis Detail Rack 4 & 5
Sheet 3 of 44
Remote PLC
I/O Chassis Detail Rack 6 & 7
Sheet 4 of 44
Remote PLC
I/O Chassis Detail Rack 10 & 11
Sheet 5 of 44
Remote PLC
Terminal Block Layout Rail 1
Sheet 6 of 44
Remote PLC
Terminal Block Layout Rail 3
Sheet 7 of 44
Remote PLC
Terminal Block Layout Rail 2 & 4
Sheet 8 of 44
Remote PLC
Terminal Block Layout Rail 5
Sheet 9 of 44
Remote PLC
Power Distribution (remote) 120 VAC
Sheet 10 of 44
Remote PLC
Power Distribution (remote) 24 VDC
Sheet 11 of 44
Remote PLC
Power Distribution (remote) 24 VDC
Sheet 12 of 44
Storage Location: Validation Files

Revision
No.

Date

Original

1/27/06

Original

6/14/06

Original

1/27/06

Original

1/27/06

Original

1/27/06

Original

1/31/06

Original

1/31/06

Original

1/31/06

Original

1/31/06

Original

1/27/06

Original

1/27/06

Original

1/27/06

Verified
By / Date

Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 199 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.

Drawing Title

Remote-N. DWG

Remote OCS Network Schematic

Architec.DWG

Revision
No.

Date

Original

6/18/06

Proposed CIP System Architecture

12/14/06

TNET2A.DWG

Thornton Transmitter T-NET-2

2/10/06

TNET1A.DWG

Thornton Transmitter T-NET-1

2/10/06

TNET2.DWG

Original

6/6/06

Original

5/23/06

Equip

Thornton Transmitter T-NET-2


Schematic
Thornton Transmitter T-NET-1
Schematic
Control Equipment Overview

Original

1/10/06

ABRemote

Allen Bradley Remote Link

Original

1/13/06

OCS-Remote

Remote OCS Network

6/10/06

Original

1/31/06

Original

1/31/06

Original

1/31/06

TNET1.DWG

Non Kaye Sheet Kaye Enclosure


1 of 5
Non Kaye Sheet Terminal Block Layout CP-02
2 of 5
Non Kaye Sheet Kaye Power Distribution
3 of 5
Storage Location: Validation Files

Verified
By / Date

Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 200 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.
Non Kaye Sheet
4 of 5
Non Kaye Sheet
5 of 5
Kaye Sheet 1
of 6
Kaye Sheet 2
of 6
Kaye Sheet 3
of 6
Kaye Sheet 4
of 6
Kaye Sheet 5
of 6
Kaye Sheet 6
of 6
Kaye Sheet 6A
of 6

Drawing Title
Kaye Panel CP-02 Scanner 1
Electrical Dwg
Kaye Panel CP-02 Scanner 2
Electrical Dwg
Kaye Enclosure Mfg

Revision
No.

Date

2/10/06

2/10/06

Original

1/31/06

Terminal Block Layout CP-05

Original

1/31/06

Kaye Power Mfg

Original

1/31/06

Scanner 1 Electrical drawing

2/10/06

Scanner 2 Electrical drawing

2/10/06

Scanner 3 Electrical drawing

2/10/06

Scanner 4 Electrical drawing

2/10/06

Verified
By / Date

Storage Location: Validation Files


Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 201 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.
CIP Kaye
Sheet 1 of 7
CIP Kaye
Sheet 2 of 7
CIP Kaye
Sheet 3 of 7
CIP Kaye
Sheet 4 of 7
CIP Kaye
Sheet 5 of 7
CIP Kaye
Sheet 6 of 7
CIP Kaye
Sheet 7 of 7

Drawing Title

Revision
No.

Date

Kaye Enclosure CIP Alarm

Original

1/31/06

Terminal Block Layout CP-22

Original

1/31/06

Kaye Power Distribution CIP Room

Original

1/31/06

Kaye Panel CP-22 Scanner 1


Electrical Dwg
Kaye Panel Filler Scanner 1
Electrical Dwg
Kaye Panel Filler Scanner 2
Electrical Dwg
Kaye Panel Lyo Scanner 3
Electrical Dwg

Original

1/31/06

Original

2/10/06

Original

2/10/06

Original

2/10/06

Verified
By / Date

Storage Location: Validation Files


Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 202 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.

Drawing Title

Revision
No.

Loop Diagrams
Loop Diagram TT-034
Sheet 1 of 68
Loop Diagrams
Loop Diagram TT-035
Sheet 2 of 68
Loop Diagrams
Loop Diagram TT-036
Sheet 3 of 68
Loop diagrams
Loop Diagram TT-040/CIT-038
Sheet 4 of 68
Loop Diagrams
Loop Diagram FT-039
Sheet 5 of 68
Loop Diagrams
Loop Diagram FT-042
Sheet 6 of 68
Loop Diagrams
Loop Diagram TT-044
Sheet 7 of 68
Loop Diagrams
Loop Diagram TT-045
Sheet 8 of 68
Loop Diagrams
Loop Diagram TT-046
Sheet 9 of 68
Loop Diagrams
Loop Diagram TT-047/CIT-048
Sheet 10 of 68
Loop Diagrams
Loop Diagram TT-043/CIT-041
Sheet 11 of 68
Loop Diagrams
Loop Diagram TT-101
Sheet 12 of 68
Storage Location: Validation Files

Date

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

Verified
By / Date

Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 203 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
DRAWINGS
List the reference drawings for the system.

Drawing No.

Drawing Title

Revision
No.

Loop Diagrams
Loop Diagram TT-103
Sheet 13 of 68
Loop Diagrams
Loop Diagram TT-104
Sheet 14 of 68
Loop Diagrams
Loop Diagram TT-105/CIT-111
Sheet 15 of 68
Loop diagrams
Loop Diagram FT-106
Sheet 16 of 68
Loop Diagrams
Loop Diagram TT-115
Sheet 17 of 68
Loop Diagrams
Loop Diagram LT-116
Sheet 18 of 68
Loop Diagrams
Loop Diagram TT-124
Sheet 19 of 68
Loop Diagrams
Loop Diagram TT-125/CIT-123
Sheet 20 of 68
Loop Diagrams
Loop Diagram FT-129
Sheet 21 of 68
Loop Diagrams
Loop Diagram TT-130/CIT-128
Sheet 22 of 68
Loop Diagrams
Loop Diagram TT-132/CIT-131
Sheet 23 of 68
Loop Diagrams
Loop Diagram TT-133
Sheet 24 of 68
Storage Location: Validation Files

Date

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

2/22/06

Verified
By / Date

Comments:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 204 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
SPARE PARTS LIST

Manufacturer

Model Number

Description

Allen Bradley

1771-ASB

Allen Bradley Remote I/O Adapter

Allen Bradley

1771-IBD

Allen Bradley 24 VDC Discrete Input Module

Allen Bradley

1771-OBD

Allen Bradley 24 VDC Discrete Output Module

Allen Bradley

1771-IFE

Allen Bradley Analog 4-20 mA Input Module

Allen Bradley

1771-OFE

Allen Bradley Analog 4-20 mA Output Module

Allen Bradley

1771-L40B

Allen Bradley 5/40 Series B PLC CPU

Allen Bradley

1771-P7

Allen Bradley Chasis Mounted Power Supply

Allen Bradley

2711-KC1

Allen Bradley Panelview

SMC

IN313-AB1

SMC Solenoid Bank Serial Interface Unit

Nematron

IWS-120

Nematron Series 120 Industrial Terminal

Thornton

772-211

Thornton Instruments Smart Transmitter Series


770PC

Thornton

774-231

Thornton Instruments T-Net Lan Gateway for 770PCs

Thornton

1025-77

25 Thornton Sensors Patch Cord

Littlefuse

225-250

Littlefuse Type 2AG 1/4 A Fuses for Thornton

Black Box

RJ-ME790A-M

Black Box RS-232/422 Converter

Allen Bradley

1784-KT

Allen Bradley DH + Communications Card

Opto-22

AC24

Opto-22 RS-422 Computer Peripheral Adapter Card

Winncom
COMMENTS:

N.A.

Winncom Serial Port Expansion Card (4 ports)

Performed By: ____________________________________________


____________

SAMPLE

Date:

Page 205 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
Reviewed By: _______________________________________
__________________

Date:

MANUALS
List the reference manuals for the system.

Vendor

Advance Industrial
Systems
Advance Industrial
Systems
Advance Industrial
Systems
Advance Industrial
Systems
Allen-Bradley

Manual Title

Revision No.

CIP/SIP System Operators Manual

Original

CIP/SIP System Editors Manual

Original

CIP/SIP System Technicians Manual

Original
Original

Allen-Bradley

CIP/SIP System Functional Design


Document
Enhanced Ethernet PLC5 Programmable
Controller Users Manual
1771-IFE Analog Input Users Manual

Original

Allen-Bradley

1771-OFE Analog Output Users Manual

Original

Allen-Bradley

1771-IBD 10-30 VDC Input Module


Installation Book
1771-OBD Output Module Installation
Book
1771-ASB Remote I/O Adapter Users
Manual

Allen-Bradley
Allen-Bradley

Date
Verified

Original

1771-2.75
1771-2.76
1771-2.48

Storage Location:
COMMENTS:

Verified By: ___________________________________________

SAMPLE

Date: ____________________

Page 206 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
Reviewed By: __________________________________________

SAMPLE

Date: ____________________

Page 207 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
MANUALS
List the reference manuals for the system.

Vendor

Allen Bradley

Manual Title

Kaye

Panelview Operator Terminal Users


Manual
Series 110/120 Installation and Terminal
Guide
Kaye Digi 4S Plus Users Guide

Thornton

770 Network Interface Instruction Manual

Thornton

770 PC Process Controller Instruction


Manual
1771 I/O Chassis power supply product
data

Nematron

Allen Bradley

Revision No.

Date
Verified

2711-812
IWS-232
First Edition
Rev 1.0

Rev D
1771-2.185

Storage Location:
COMMENTS:

Verified By: ___________________________________________

Date: ____________________

Reviewed By: __________________________________________

Date: ____________________

SAMPLE

Page 208 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
STANDARD OPERATING PROCEDURES LIST
SOP #

REVISION

EFFECTIVE
DATE

TITLE

COMMENTS:

Performed By: ____________________________________________


_____________________

SAMPLE

Date:

Page 209 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION
AMENDMENT(S) AND DEVIATION(S)
Any deviation that was determined during the execution of the CQ portion of this Protocol, must be
noted below.
Deviation No.:
AMENDMENT/DEVIATION:

Prepared By: ___________________________________________

Date: ____________________

Approved By: ___________________________________________ Date: ____________________

SAMPLE

Page 210 of 211

BIG PHARMACEUTICALS, INC.


Protocol No.: SAMPLE
Date: November 21, 2006
System Name: CIP / SIP Control System

Building/Area: Building 88
Room: Powerhouse

CONTROLLER QUALIFICATION

SUMMARY AND CONCLUSIONS


Summary

Verified By / Date

The system has been reviewed as outlined in the


Controller Qualification Section of this Protocol.
The requirements of the Controller Qualification Protocol
have been completed and appropriate data forms are
reviewed.
Comments, Amendments and Deviation, and special
notes related to the Controller Qualification of this
system/equipment have been reviewed and approved as
noted.
Conclusion

SAMPLE

Page 211 of 211

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